MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Patient states that some of her cassettes caused an error on the pumps and she had to use a new one to get it to start working again.Not while in use, no injury to patient, replacement not needed, back ups were available, pumps working fine; is the actual device available for investigation? as stated above, pumps are working fine.No reason to send for investigation; is the infusion life-sustaining? yes; what is the outcome of the event? resolved, new cassettes sent out serial number and expiration date are unknown.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12703997
• MDR Text Key: 278855822
• Report Number: MW5104973
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1